Greetings. Welcome to the Trinity Biotech Third Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now pleasure to introduce Eric Ribner, Investor Relations. Thank you. Eric you may begin..

Thank you very much. Before we begin, please note that statements made during this presentation may be deemed forward-looking statements within the meaning of federal securities laws. These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements.

These risks include but are not limited to those set forth in the risk factor statements in the company's annual report on Form 20-F filed with the SEC. Trinity Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events.

I will now hand the call over to John Gillard, President and CEO of Trinity Biotech, who will give an overview of Q2 performance and a business update. John will be followed by the company's Chief Financial Officer, Louise Tallon, who will give further details on third quarter financials. John, I'll turn it over to you..

One, large and important disease areas. Two, diagnostics that lead to differentiated treatment paths for patients and three, utilization of sophisticated next generation technology platforms. For example, prostate cancer is the most common non-skin cancer among men in the U.S., with about one in eight men diagnosed during their lifetime.

And the cost for diagnosis and treatment is estimated at over $100 billion annually. The ability to accurately monitor prostate cancer progression is critical as the disease can often be slow growing and unnecessarily invasive interventions, such as prostate biopsies can lead to significant complications.

The epiCaPture test could significantly reduce the frequency of these interventions, thereby improving the quality of life for patients. The epiCaPture test offers a breakthrough approach to monitoring disease progression by using epigenetic analysis.

This technology is innovative and new to Trinity Biotech, thus allowing us to move up the technology and value curve in a large-scale disease area and introduce our company to the high value oncology market.

Similarly, our other new acquisition, Metabolomics Diagnostics, addresses the large-scale issue of preeclampsia, which impacts up to 5% of pregnancies in the U.S. and which can cause serious illness or death in affected mothers and babies.

The Metabolomic Diagnostics proprietary PrePsia technology has been shown to deliver improved prediction of preterm preeclampsia risk at week 12 of pregnancy. Early detection of preeclampsia would allow for the prescription of effective medication, which can significantly reduce the risk of often serious health issues for mothers and their babies.

The Metabolomics test uses mass spectrometry combined with machine learning powered bioinformatics, which again is a new and innovative technology to Trinity Biotech. This increases our exposure to and capabilities in machine learning, which is increasingly becoming a critical aspect of modern healthcare and in particular diagnostics.

Regarding Novus Diagnostics, in which we have made a 12.5% strategic investment, our strategic rationale is to leverage our existing capabilities to support the development and commercialization of Novus' groundbreaking technology.

This is a rapid 15-minute sepsis test that can provide life-saving information to physicians to enable faster diagnosis and timeline treatment. Novus' platform addresses key limitations in current sepsis diagnostics, such as the delay in results.

This rapid point-of-care solution is expected to significantly improve sepsis outcomes by enabling faster diagnosis and timely treatment, potentially saving lives and reducing the over $50 billion estimated annual cost of sepsis related hospitalization in the U.S. Now turning to the second of the three key areas I want to focus on today.

Our comprehensive transformation plan on which we continue to make significant progress and remains on track. Our aim with these initiatives is to enhance the value of our existing business lines by transforming operations to address the root causes of historical inefficiency and pave the way for profitability growth on a larger scale.

Under this plan, we have several objectives to accomplish. First, reduce costs through consolidation and offshore of manufacturing. In this regard, we have now successfully completed the transfer of our second rapid HIV product manufacturing process to our offshore manufacturing partner.

In a significant milestone, we have made submissions to the relevant international regulator to commercial production of both rapid HIV tests with our offshore partner. We expect offshore production of both products to begin in Q1 2025. We expect this shift will be gross margin accretive and provide meaningful working capital benefits.

We are also beginning to transfer some of the more technical aspects of production of both of our rapid HIV tests to our offshore partner. In fact, we already have a team on-site for the next two weeks with our partner. Once in place, this change should support further gross margin and profitability enhancements.

We have continued to make significant progress in consolidating our main hemoglobin manufacturing activities currently carried out at our Kansas City plant into two of our other existing plants. We remain on track to seize the main manufacturing activities at our Kansas City site by the end of 2024.

We have recently also informed staff at our autoimmune test manufacturing site at Buffalo, New York of our intention to consolidate its main manufacturing activities into our Jamestown, New York plant. We expect to see some main manufacturing activities at our Buffalo site by the end of Q1 2025. We are also focused on optimizing our supply chain.

In this regard, we've continued to identify further material saving opportunities in our rapid HIV test supply chain and expect to have them in place by the end of Q1 2025. Lastly, we plan to centralize and offshore many of our corporate services to drive both efficiency and agility.

As planned, our offshore corporate services site is now live with a number of functions operating from this site. We expect to add additional functions through the end of 2024 and into Q1 2025. These changes will support improved profitability.

Our comprehensive transformation plan is ambitious and wide ranging, impacting almost every aspect of our business. I would like to take this opportunity to thank our staff, including those that are set to leave the business as part of the transformation for their support and cooperation during this important journey.

Once completed, I believe we will have a much more efficient and modernized operating model. With just two main manufacturing sites, focusing on the more complex aspects of our products, one in the U.S. and one in Ireland, with less complex manufacturing activities either offshored or outsourced.

This simplification is expected to drive significant efficiency and profitability enhancement. In addition, our centralized and offshore corporate services side should give us a more efficient and effective platform to support the business.

Given our continued strong execution on our wide range comprehensive transformation plan, we are today reiterating our guidance to achieve approximately $20 million of annualized run rate earnings before interest tax depreciation and share options cost or EBITDASO, excluding impairment charges and once off items, and annualized run rate revenues of approximately $75 million by Q2 2025.

And we will continue to execute towards this. Finally, and thirdly, I'm extremely pleased to be closing out a difficult period for the company over the past year. One of my top priorities when I took on the CEO role in December 2023 was to address the company's pre-existing NASDAQ listing requirement deficiencies.

We have now regained compliance with NASDAQ listing requirements and removed an important overhang on our stock. We are grateful for the continued support of our shareholders, partners and employees during this process.

So to conclude, overall, I am very satisfied with the significant progress we have made over the past few months on our ambitious priorities.

We will remain focused on disciplined execution in our comprehensive transformation program, so that we as rapidly as possible transition to profitability, while at the same time preparing the company for significant future growth with our exciting programs in CGM, prostate cancer and preeclampsia.

I would like to thank you all for your attention, and I will now hand you over to Louise Tallon, our Chief Financial Officer, to discuss the Q3 financial results in more detail..

Thanks, John. I'm delighted to go through our Q3 results and highlight some of the progress the company has made during the last quarter. Starting with our revenue, our revenues for Q3 2024 were $15.2 million which is just over 3% higher than Q3 2023.

Our point-of-care revenue continues to have a large impact on growing our business, increasing by $2,7 million to $4.3 million. This is an increase of 60% compared to Q3 2023 driven by our TrinScreen product which has sales of approximately $2.4 million.

We have reiterated our guidance for TrinScreen sales of approximately $10 million for the full year 2024. Our clinical laboratory revenues were $10.8 million which is a decrease of 9% compared to Q3 2023. Included in these revenues was a strong performance from our clinical chemistry portfolio, which grew by almost 80% year-on-year.

This increase in revenue was offset by a revenue decrease in our hemoglobin business, which was 70% lower year-over-year.

This occurred due to decreased instrument sales during the period combined with higher consumable sales in Q3 2023, which as John noted was influenced by the phasing of hemoglobin revenues from certain customers throughout the prior year. Moving on to our gross profit for the quarter which was $5.3 million and represented a gross margin of 35%.

This was broadly consistent with the margin for the comparative quarter in 2023 when you exclude the stock obsolescence costs that were included in 2023 results. Within our gross margin, there are two pieces of key businesses that affect the results. Firstly, we have positive margins with our hemoglobin’s business.

We're now manufacturing costs through supply chain initiatives and from our revised and highest manufacturing process. Secondly, in offsetting this, the Trin Screen HIV sales are currently diluting our overall gross margin percentage.

We we're expecting this to improve incrementally over the next three quarters due to the increased operational efficiency through automation and expected transfer of assembly activities to a lower cost location which begins Q1 2025. We have some favorable movement in expenses year-on-year.

Within research and development expenses, they were $200,000 less than the comparable quarter. We also capitalized $2.1 million for the quarter in relation to our biosensor development as we continued our development activities post the Waveform transaction we completed in January.

Our SG&A expenses were $6.5 million in the quarter compared to $7.7 million in Q3 2023. This is a substantial decrease of $1.2 million and is a clear indication of our journey on cost reduction where we've lowered overall employee remuneration costs.

This quarter, we've also incurred restructuring costs of approximately $300,000 related to the comprehensive transformation plan, which John described earlier. This brings total costs year-to-date to $2.3 million with further costs expected in Q4 as a result of our ongoing transformation plan.

These costs mainly comprise of termination payments, factory closure costs and costs associated with the transfer of activities to the offshore service provider. The majority of the cash outflow related to these restructuring costs will happen in Q4 2024 and Q1 2025.

Overall, we now reported an operating loss of $2.6 million in the quarter compared to an operating loss of $4.5 million in Q3 2023. Our net financial expense in the quarter increased by approximately $200,000. This increase is due to our term loans, a result of the additional loan drawdowns related to the Waveform transaction earlier in the year.

This brings us to a net loss post tax and interest position of $4.8 million in the quarter compared to $6.7 million loss in the same quarter last year. The adjusted EBITDASO was one of our primary KPIs and represents the loss before depreciation, amortization, impairment charges, restructuring costs, tax, interest and share-based payments.

For the quarter, we report adjusted EBITDASO of $1.4 million loss compared to $3.5 million loss in the equivalent period last year, while our basic loss per ADS was $0.46 compared to $0.88 in Q3 2023. Finally, I'll talk about our cash for the quarter. The cash balance decreased from $5.3 million at June 30 to $2.8 million at the end of September.

Cash used by our operations was $3.6 million in the quarter, an improvement of $1 million compared to Q3 2023. Although there was improvement on the prior year, I note the working capital outflow in the quarter. Trade and trade receivables have increased relating to large receivables associated with our TrinScreen product.

We expect to show improvements here in Q4. We had investment cash outflows of $3.1 million which mainly related to our R&D capital expenditure for CGM and hemoglobin products as well as cash related to the acquisition of Metabolic Diagnostics. Cash inflow from financing activities were $4.2 million in the quarter.

During the quarter, the company entered into an aftermarket offering agreement, which resulted in a positive net cash flow of $7.1 million. Now I'll hand you back to Eric for any questions..

Thank you. And I guess we'll take questions now. Yes..

Thank you. [Operator Instructions]. Our first question is from James Sidoti with Sidoti and Company. Please proceed..

Hi, good evening. Thanks for taking the questions. It's nice to see earnings coming out before the quarter -- the next quarter has ended. So it seems like you're back on track that way, which is nice to see. So regarding the third quarter, you said you still expect the TrinScreen sales around $10 million.

So it sounds like you're looking for a little over $3 million of revenue from that in the Q4.

Does that sound right?.

Hi, Jim. Good to talk to you. Thanks for your question. Yeah, I think that's fair.

As we've seen over many years with HIV rapid sales, there can be quarter-on-quarter variation in ordering patterns and because the order sizes for TrinScreen are much larger typically than we would have for Uni-Gold that leads to I think it was a higher overall impact in terms of our revenue. And yes, we would expect about $3 million for Q4..

Okay. And with regard to the Premier Instruments, it sounds like those sales were a little lower this quarter as some customers waited for the new column to come out.

Do you think that business comes back in the Q4 or do you think that business is lost or do you think it comes back in 2025?.

Yes, I think the core revenue for consumables there is broadly consistent quarter-on-quarter, which we would expect, right, given the nature of that business where you've got typically instruments placements and a consistent level of throughput in terms of those instruments. I think that variation was more really got to do with 2023.

There was some high variation in ordering patterns across particularly one customer and we took steps earlier this year to kind of normalize their demand because it creates operational challenges where you're having very high spikes in demand over particular quarters. So we've kind of more smoothed it out.

In terms of the other differential revenue predominantly down to instrument placement sales being reduced as we've been consistent, I think throughout the year, we're not pushing them as hard as we will be in the past because we think the new column proposition is a much better proposition given the higher level of tests that those columns do and the lower level of calibrations etc.

required for customers. So while we're rolling out the new columns and betting in that value proposition, we're not pushing instruments as much as possible because as you know instrument sales for us typically have been quite gross margin dilutive and in some cases significantly cash flow negative.

So we think that the value proposition is better with the new column and we prefer to sell on the basis of that. We also have made some significant supply chain changes in our supply chain for instrumentation which allows us to have a much reduced cost of instruments.

And we are also waiting for that to fully come through before we start pushing again. So a temporary reduction I would say Jim, but in terms of our instrument placement revenues, but overall our level of throughput and consumables revenues is consistent..

Okay. And it sounds like you're making some pretty significant progress on the cost reduction side.

Did I hear you say you think that these first phase of initiatives they should be complete by the end of Q1 of 2025?.

Yes, Jim. And look I appreciate completely that it is somewhat frustrating for investors hearing about these initiatives, but not seeing a huge, huge impact in terms of financials as yet.

We operate in a highly regulated environment as people know and changes in terms of our operating structure require significant planning and execution, right? And I do believe and I know from other people who are very experienced in the industry, we are moving at a very fast pace, a controlled but very fast pace.

There is nobody beyond myself and Louise that would like to see this happen much quicker. We would like this to be done as quickly as possible. But the truth is it just takes time in this industry for all the various steps with checks and balances that are properly there to be carried out.

And so for that reason we had always expected most of these changes to be affected by the end of Q4 this year or very early in 2025. And that's where we expect the real profitability and cash flow benefits associated with those to come on stream.

So as I mentioned in my prepared remarks, we do expect we are on the cusp of a step change in financial performance and that should build throughout the rest -- from early 2025 towards the end of the year..

Okay. And then just a couple more.

What's the timeline for the two tuck-in deals you did, the PSA test, the preeclampsia test? What's the timeline do you think to commercialize those tests? And will they be sold throughout the United States or are they just New York test?.

Yeah. So if I take the Metabolomic test, the preeclampsia, we expect that to be revenue generating in the second half of 2025. They will be sold initially as lab developed tests. We would expect that we will be able to provide that testing service all around the U.S.

because our lab is New York State certified which basically gives the right to be able to provide testing services to people in 50 states. And so that is the way that we will initially roll out that test is as a service.

And as Immco has done for many, many years, we will then look to get traction for that test in the market through interaction with KOLs, so key opinion leaders, physicians, etc., Jim.

And then assuming that we get the level of traction that we expect from providing that test as a service, we would then typically look to get an FDA approval as a 510(k) for example on that test and then sell it as a test kit to other laboratories all across the U.S. and possibly internationally.

With regards to the prostate cancer test for Metabolomics, again we're very excited with that opportunity and the opportunity to get into the oncology space.

There is more work to be done on that in order to get us into the necessary kind of stage in order to start offering testing services out of our New York State certified lab and expect that will be revenue in 2026.

But given the nature of the test and the market that it focuses on, I believe there's an opportunity for us to create very significant value in the short-to-medium term by further developing that test.

So our plan would be to roll it out in the same way but I think we can add a lot of value given the nature of the test, the type of technology, what it does for patients and in line with its intended use and the space that it operates in..

All right.

And the last one for me is, what do you expect the share count to be in the Q4 as a result of these two acquisitions?.

I don't have that number right now. We can go back to you on that, Jim. We can go back to you on that..

Okay. Okay. Thank you..

Thanks, Jim..

Our next question is from Paul Nouri with Noble Equity Funds. Please proceed..

Hey, good morning. I guess the looking at these goals for the second quarter of next year, I guess pretty much calls for a sales increase of 20% and EBITDA. So quarterly turnaround of $6.5 million.

So maybe -- I know all the initiatives you have and it's great that you're drilling into the details publicly, but what are the biggest maybe two or three items that will get you there in the next few quarters?.

Yes. Thanks, Paul. Look, for commercial reasons as you can imagine, we're dealing with partners. So I don't want to give particular details around the savings we get from different initiatives. But I think it's safe to say the ones that we have noticed are the biggest ticket items that we have, right.

The drains on profitability per our analysis has been significant number of factories operating not at full capacity and because we're in a very highly regulated industry that comes with a significant amount of overhead, right? So reducing down from three in the U.S.

to just one will have a big impact, right? And then offshoring some of the less complex aspects of our operations to a lower cost location and to a partner who's also manufacturing other products and that was effectively spread a lot of that overhead. So they are each the biggest contributors.

The offshoring and consolidation of corporate services has an impact. It's probably on the lower side than the physical infrastructure ones in terms of manufacturing, but again does add. I think the key benefit around that would be modernization of our processes and further agility and ability to scale particularly as we push out the CGM product.

So that is a cost save move but also further agility focused as well.

Does that make sense?.

Yes. Thank you.

I guess looking at TrinScreen and the revenues for next year are – are most of the revenues for next year on TrinScreen expected to be from new tenders or building on the existing tender from this current year?.

Yeah. Thanks, Paul. Good question. So a mix. So we are in a number of valuation processes for TrinScreen. I know as a long-time investor in the company, Paul, you know as well as anyone there is uncertainty around the timing of those tenders and those evaluation processes.

And they can move from quarter to quarter depending upon different priorities within the health organizations, government changes, etc., right? And that's something that we need to be agile on and ready to react.

And I think our outsourced manufacturing will allow us to be more agile and to react to shorter notice in terms of scaling up for big wins, right? And that was one of the drivers in addition to cost savings. So we would hope to win and do expect to win additional tenders and evaluations for 2025. And when exactly they will come in, we don't know.

We have an idea. That's not something we will go into publicly. But as you know, it can shift around. But we've done what we needed to do this year on TrinScreen, which was supply the market at a very, very big volume from the off. So we've proven that we can manufacture and supply a very high volume of product on time to the highest levels of quality..

Okay, great.

And then final question, how much capacity is remaining on the ATM?.

I think there's about less than a million on the current ATM filing..

Okay, thank you..

Thanks, Paul..

We have reached the end of our question-and-answer session. I would like to turn the conference back over to management for closing remarks..

Thank you, Sherry. Thank you everybody for your attention. We appreciate your interest in the company and your support as we continue with this transformation journey. And we look forward to speaking with you over the next coming weeks..

Thank you. This will conclude today's conference. [Operator Closing Remarks]..